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A Phase I, Open-label Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of EMD525797 After Single Dose and Repeated Dosing at Different Dose Levels in Japanese Patients With Advanced or Metastatic Solid Tumors and Progressive Diseases Following Prior Chemotherapy

Trial Information

A Phase I, Open-label Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of EMD525797 After Single Dose and Repeated Dosing at Different Dose Levels in Japanese Patients With Advanced or Metastatic Solid Tumors and Progressive Diseases Following Prior Chemotherapy

Study Design:

Outcome Measure:

Dose-limiting toxicities (DLTs) occurring during the first 4 weeks of treatment, using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.

Outcome Description:

Any Grade 3 or 4 hematological or non-hematological toxicity (with the exception of toxicities detailed below) occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor.
Toxicities not considered to be DLTs are as follows:
Allergic reactions or anaphylaxis; Any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which are reversible within 7 days, unless the Investigator decides this event is clinically significant.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR200017-007

NCT ID:

NCT01327313

Start Date:

January 2011

Completion Date:

December 2012

Related Keywords:

Solid Tumor

alpha v integrin

antibody

solid tumor

Japanese

Neoplasms

Name

Location

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